Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269243
Status:
COMPLETED
Last Update Posted:
2006-02-08
First Post:
2005-12-20
Brief Title:
Management With Accupril Post Bypass Graft
Sponsor:
Montreal Heart Institute
Organization:
Montreal Heart Institute
Study Overview
Official Title:
The Ischemia Management With Accupril Post Bypass Graft Via Inhibition of the coNverting Enzyme IMAGINE Trial
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Angiotensin converting enzyme ACE inhibitors have been shown to improve survival and to reduce the risk of cardiovascular events in some groups of patients following myocardial infarction This study is designed to test whether early initiation 7 days of an ACE inhibitor post-coronary artery bypass graft CABG would reduce cardiovascular events The trial was a double-blind placebo controlled study of 2553 patients randomly assigned to quinapril target dose 40 mg daily or placebo followed up to 43 months
Detailed Description:
The IMAGINE study is a double-blind placebo controlled parallel group randomized multi-centre international study conducted in patients who have undergone CABG The research protocol was approved by the ethics committee of all participating institutions and all patients gave written informed consent The data were collected and analysed by an independent clinical research organization
Patients were screened for eligibility and randomized in hospital within seven days post-CABG except for France where randomization could occur within ten days post-CABG Starting November 6 2001 given the increasing evidence of benefit of ACE inhibitors in patients with diabetes and renal disease14 all patients requiring insulin or with type II diabetes and micro-albuminuria were no longer eligible for the study Those already in the trial were treated according to the clinical judgement of the treating physician
Of patients screened in 57 sites in Canada the Netherlands Belgium or France 2 553 patients approximately 5 percent of patients screened were randomized post-operatively to quinapril either 10 or 20 mg or to placebo Randomization was done centrally was un-stratified block-based and computer generated If tolerated patients were up-titrated to 40 mg of quinapril or its placebo equivalent within hospital or if not tolerated later post-hospital discharge Patients were followed for twenty-four months at which time they were invited to continue until 43 months of follow-up or withdrawn if they did not wish to extend their participation in the trial
The original primary endpoint consisted of time to first occurrence of any of the composite of cardiovascular death or resuscitated cardiac arrest nonfatal myocardial infarction coronary revascularization unstable angina requiring hospitalization and documented angina not requiring hospitalization On January 14 2003 the Steering Committee concluded that the required number of endpoints would likely not be reached without modification of the primary endpoint Stroke and congestive heart failure requiring hospitalization were thus added to the primary endpoint and sample-size was increased to 2 500 patients
The secondary endpoints included 1 time to first occurrence of the following composite of cardiovascular death or resuscitated cardiac arrest nonfatal myocardial infarction coronary revascularization or stroke 2 incidence of any of the above mentioned secondary endpoints 3 time to first occurrence of the composite primary endpoint with the addition of the following transient ischemic attack and any cardiovascular event requiring hospitalization 4 incidence of any secondary endpoints included in 3 and 5 time to occurrence of death from any cause All endpoints were adjudicated in a blinded fashion by an endpoint committee based on pre-defined definitions for each endpoint
Patients were screened for eligibility and randomized in hospital within seven days post-CABG except for France where randomization could occur within ten days post-CABG Starting November 6 2001 given the increasing evidence of benefit of ACE inhibitors in patients with diabetes and renal disease14 all patients requiring insulin or with type II diabetes and micro-albuminuria were no longer eligible for the study Those already in the trial were treated according to the clinical judgement of the treating physician
Of patients screened in 57 sites in Canada the Netherlands Belgium or France 2 553 patients approximately 5 percent of patients screened were randomized post-operatively to quinapril either 10 or 20 mg or to placebo Randomization was done centrally was un-stratified block-based and computer generated If tolerated patients were up-titrated to 40 mg of quinapril or its placebo equivalent within hospital or if not tolerated later post-hospital discharge Patients were followed for twenty-four months at which time they were invited to continue until 43 months of follow-up or withdrawn if they did not wish to extend their participation in the trial
The original primary endpoint consisted of time to first occurrence of any of the composite of cardiovascular death or resuscitated cardiac arrest nonfatal myocardial infarction coronary revascularization unstable angina requiring hospitalization and documented angina not requiring hospitalization On January 14 2003 the Steering Committee concluded that the required number of endpoints would likely not be reached without modification of the primary endpoint Stroke and congestive heart failure requiring hospitalization were thus added to the primary endpoint and sample-size was increased to 2 500 patients
The secondary endpoints included 1 time to first occurrence of the following composite of cardiovascular death or resuscitated cardiac arrest nonfatal myocardial infarction coronary revascularization or stroke 2 incidence of any of the above mentioned secondary endpoints 3 time to first occurrence of the composite primary endpoint with the addition of the following transient ischemic attack and any cardiovascular event requiring hospitalization 4 incidence of any secondary endpoints included in 3 and 5 time to occurrence of death from any cause All endpoints were adjudicated in a blinded fashion by an endpoint committee based on pre-defined definitions for each endpoint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None